Antonella Ficorilli, from Epidemiologia e Prevenzione “Giulio A. Maccacaro” (Italy), presented during the session “Citizen science and health” on September 7th, 2020 at the ECSA 2020 Conference the “Investigating the Process of Ethical Approval in Citizen Science Research: The Case of Environmental Epidemiology” developed in the framework of CitieS-Health project, funded by European Union’s Horizon 2020 research and innovation programme.
Image: Situation of the CitieS-Health pilot projects, indicating the main area of research.
The ethical framework in traditional research is about the research subjects, without making them to actively participate in the process. The original aspect in citizen science (CS) projects, as the CitieS-Health five pilot studies, is to involve citizens as research subjects as well as active participants in all phases of the study, including the ethical part. This is a novel characteristic in research with human subjects. From ethics about citizens as research subjects to ethics about citizens as research subjects and ethics FOR citizens as collaborators. “How we can handle the ethics for citizens as collaborators in all phases of the study is a key challenge”, explained Ficorilli.
The strategy envisioned by the CitieS-Health project is a two-step ethical process with templates for information sheets and consent forms for each step. In the first step, citizens are asked to contribute to debating and co-designing the study protocol jointly with researchers. In the second step, citizens are called to participate in the co-designed study as research subjects and active participants.
In order to accomplish this process, new elements have been or should be introduced in the study protocol (e.g. the names of individual citizens who have co- designed it and related documents, as co-proponents together with researchers), the information sheet (e.g. the double role that citizens who decide to take part in the study will play) and the informed consent (e.g. a “signed agreement of collaboration”).
Both the Barcelona and Lucca Medical Ethics Committees, addressed with regard to the population engagement (first phase), claimed that the matter was not within their competence. The response of the Research Ethics Committee of the University of Florence, with regard to the population engagement (first phase), provided approval with the recommendation that individual data be accessible only to researchers not to lay people, who should have access only to aggregate data. The Kaunas Regional Committee for Biomedical Research Ethics, with regard to the epidemiological study protocol (second phase), claimed that all decisions and responsibility on quality and privacy of data is under the principal investigator in charge.
Feedback from Ethics Committee
Feedback leaves the question open on how to handle and legitimise the shared responsibilities in CS projects. The key challenges in making people participate in ethical part on CS projects were “How can we handle the current lack of legal recognition of the involvement of citizens as scientists?” and “How can we handle the diversity among European countries concerning the competent Ethics Committees?”.
Lessons learned and recommendations
￼We have learned that the public debates with citizens are essential in order to produce a co-designed protocol; to implement the study in a participatory way; and to devise participatory governance.
“The novelty of ethics FOR citizens as collaborators poses many challenges. It should be addressed by adapting to the specific context of the research”, concluded Ficorilli.